Job Title: Design Quality Engineer

Location: Irvine, CA (Onsite)

Overview:

Seeking a Design Quality Engineer II to support medical device new product development by ensuring compliance with design controls, risk management, and regulatory requirements. The role focuses on quality system support, design verification and validation, and successful transfer of products to manufacturing.

Required Experience:

• Medical device product development lifecycle experience
• Design Controls (FDA 21 CFR 820, ISO 13485)
• Risk Management (ISO 14971, FMEA)
• Design Verification & Validation (DV/VV planning and reporting)
• Ability to read and interpret CAD drawings
• Strong knowledge of US and international medical device regulations